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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K000611
Device Name STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
Applicant
Bd Biosciences
2350 Qume Dr.
San Jose,  CA  95131 -1807
Applicant Contact JO-ANN E FABILA
Correspondent
Bd Biosciences
2350 Qume Dr.
San Jose,  CA  95131 -1807
Correspondent Contact JO-ANN E FABILA
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/23/2000
Decision Date 05/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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